Cleared Traditional

A.D.T. PROCEDURES TRAY (K812297) - FDA 510(k) Clearance

Class I General Hospital device.

K812297 · A.D.T. Lab Industries · General Hospital
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Sep 1981
Decision
45d
Days
Class 1
Risk

K812297 is an FDA 510(k) clearance for the A.D.T. PROCEDURES TRAY. Classified as Lubricant, Patient (product code KMJ), Class I - General Controls.

Submitted by A.D.T. Lab Industries (Mchenry, US). The FDA issued a Cleared decision on September 28, 1981 after a review of 45 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6375 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all A.D.T. Lab Industries devices

Submission Details

510(k) Number K812297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1981
Decision Date September 28, 1981
Days to Decision 45 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 129d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KMJ Lubricant, Patient
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6375
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.